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NCT Number: NCT07138326

Impact on the Absorption of Drugs in Ostomy Patients

Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.

For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).

The clinical trial´s results will answer the following questions:

* Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way? * Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here.

Recorded and evaluated:

* Relevant patient data * Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

WiGeV Klinik Ottakring

Vienna, State of Vienna, 1160, Austria

Location status: Recruiting

Location contact

Irene Lagoja, Dr

CONTACT

[email protected]

+431491505508

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Planned inclusion criteria:

  • Male and female patients aged ≥18 years
  • Belonging to a collective
  • Ileostomy since ≥7d
  • Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved.
  • Taking ≥1 of the following active substances since ≥7d:
  • Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine
  • NOACs: edoxaban, rivaroxban, apixaban

Exclusion criteria

Insurmountable language barrier

Treatment and study plan

Monitoring

Diagnostic Test

Monitoring

Primary outcomes

  1. Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study

    Time frame: 18 month

    During a routine blood draw, an additional 2ml (Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine)or 3.5 ml (NOACs: edoxaban, rivaroxban, apixaban)of blood is taken. In this sample, the drug levels are determined using a validated method ( LC-MS/MS (Psychotropic drugs) or chromogenic test (NOACs)). The drug level [µg/ml] determined in this way is compared with the therapeutic target range specified in the respective approval studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Lagoja, Dr

CONTACT

[email protected]

+431491505508

Stefanie Hehenberger, Mag

CONTACT

[email protected]

+431491505508

Sponsors and collaborators

Lead sponsor

WiGeV Klinik Ottakring

Other

Registry information

Official study title

Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen

Acronym: STAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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